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FDA 510(k)

Universal Cannula Seal (5-12 mm)

K-Number: K181395 · 2018-07-27

ApplicantIntuitive Surgical, Inc.
Decision Date2018-07-27
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Universal Cannula Seal (5-12 mm) is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2018-07-27 under approval number K181395. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Universal Cannula Seal (5-12 mm)?

Universal Cannula Seal (5-12 mm) is a medical device that received FDA 510(k) clearance on 2018-07-27. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K181395.

When was Universal Cannula Seal (5-12 mm) approved by the FDA?

Universal Cannula Seal (5-12 mm) received FDA 510(k) clearance on 2018-07-27, under approval number K181395.

What company makes Universal Cannula Seal (5-12 mm)?

Universal Cannula Seal (5-12 mm) is manufactured by Intuitive Surgical, Inc..

What is the FDA product code for Universal Cannula Seal (5-12 mm)?

The FDA product code for Universal Cannula Seal (5-12 mm) is GCJ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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